MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MINISTRY C SECTION PACK

Catalog Number	DYNJ82919
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had a gown in our c-section pack have significant strike through this morning.".
Additional Manufacturer Narrative
According to the customer, while using a "level 3 gown" from the c section pack on (b)(6) 2023, the surgeon had "blood" strikethrough the gown onto her "arm".No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted that would have contributed to the reported issue, and the finished good pack build was reviewed with no issues that might have an impact on the issue.The reported problem could not be confirmed because no sample or photo was received; the cause was documented as dc: traced to user knowledge.The surgical gowns currently used for the pack are classified as aami pb70 barrier level 3 rated and are designed to be fluid resistant, however with enough force it may allow strikethrough to occur; based on these details, the item performed to specifications.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-MINISTRY C SECTION PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50210562
• Report Number: 1417592-2026-15422
• Device Sequence Number: 17672702
• Product Code: OHM
• UDI-Device Identifier: 40195327219278
• UDI-Public: 40195327219278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ82919
• Device Lot Number: 23EBB359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown